Olympus EMEA

Responsible for over 25 locations in the EMEA region in regards to their CAPA Skillset. Helping 200 people on a daily basis in identifying, initiating, investigating, implementing and successfully closing CAPAs more easily.

Global Principal Quality Engineer (CAPA)

Responsible for the CAPA performance of over 20 sales, service and repair locations in the EMEA region. 

Proudest achievement: 
Winning the company-wide "Most Valuable Project" award in 2022 with my team for implementing global quality processes across 60 locations in the Americas, APAC, China, EMEA and Japan.

Quality Management Specialist

Nordantech

"For 92% of companies, transformation is a constant challenge."

"70% of all transformations fail."

Do the math now ...

In my role at Nordantech, I helped our clients master challenging and complex company transformations, reorganisations and other strategic projects.

Business Development Manager

Johnson & Johnson

In my role as project lead, I was working qualification, validation and CAPA projects in the Quality Operations laboratories.

Proudest achievement: 
Gold Award for the implementation of a capacity planning software to introduce daily scheduling of analytical tests in the 4 labs of the Quality Department for 40 lab staff and 400 different analytical test methods for over 4000 item codes.

Quality Lab Scientist / Project Lead

Chemgineering Gruppe

Regulatory Affairs (MPG/MDD; 21CFR820)
• Classification of Medical Devices in Compliance to Annex IX (MDD) & Derivation of Regulatory Requirements

Quality Systems (ISO 13485)
• Creation & Implementation of SOPs for Design Control, Supplier Management, Qualification/Validation, Work Instructions, Forms & Reports

Risk Management (ISO 14971; FMEA)
• Creation & Review of Risk Analysis Documents and Leading of Process FMEA Workshops

Qualification/ Validation (Process & Test Methods)
• Creation of DQ/IQ/OQ/PQ Documents for Process & Physical Measurement Equipment

Dual Education Student / Junior Consultant

I've reviewed too many Medical Device CAPAs over the last 10 years.

I think I've seen almost every mistake there is ...

Some of my "favorites":

- Initiating CAPA without gathering facts
- Setting up KPIs but not monitoring them
- Confusing Correction with Corrective Action

To be honest - I've made many of these mistakes myself. 

Luckily, I learned and improved.

Over time, I even took on bigger responsibilities.

Some projects which I really enjoyed:

- Process harmonizations for 60 sites
- Setup of training programs for 1.000+ people
- KPI dashboard implementations for 813 CAPAs

My learnings were paired with painful experiences.

I want to save you from all of them. 

My goal is to help you:

1. Avoid CAPA related audit findings or 483s
2. Implement meaningful metrics for your CAPAs
3. Train your people so they close records effectively

So what are you waiting for?

If you want to talk, DM me or let's connect!

And if you're shy - follow me. 

Best,
Georg

It's week 2 of being self-employed.

Last week I:

• posted 4 times
• reached 11,041 people on LinkedIn
• created my company page (Elevate CAPA)
• started preparing for my speaking gig in Nov.
• had a call to discuss an NC/CAPA process setup

But I also took care of myself and family:

→ brought kids to daycare 3x, picked up 4x
→ had no processed foods or DoorDash
→ worked out 3 times + 2 times cycling
→ called my mom almost every day
→ averaged 10.647 steps daily

What I try to do better this week:

- more posts
- start working on a webinar for y'all
- watching at least 1 movie with my wife

I am amazed by how much I wanted to achieve ... 

And how little I actually finished.

But I guess it's normal when you're doing something new.

It's exciting.

But still a little bit scary.

Which means I'm just a normal, sane human.

How about you? Anything new for this week?

PS - The picture is from my recent trip to China. Man, I miss the food ...

Georg Digel

Better NC&CAPA performance without adding complexity or hiring more people

Last Friday, I had an interesting call with a QA head from a medical device company in Switzerland.

His question was straightforward:

"Should we separate NC and CAPA in our new eQMS, or combine them?"

It's a question many quality leaders struggle with.

And here's what I told him:

Combining processes will eliminate redundancies.

Otherwise, this will be the future of your people:

1. You initiate a CAPA after you create an NC
2. You copy & paste the description from the NC
3. You copy & paste the affected items
4. You copy & paste the risk assessment
5. You copy & paste the ...

You get my point.

You might have to review for completion or add some details once it's an 'official CAPA', still ... 

A lot of the information is the EXACT same.

But there's a catch if you combine processes:

You need clear criteria for when 'real' root cause investigations and corrective actions are required.

Without them, you'll face serious challenges:

• Every NC becomes a CAPA by default
• Your system is cluttered with redundant records
• Investigations are shallow and identify symptoms
• Critical problems get lost in the noise
• Teams waste time on minor issues

I've seen it happen too often:

Your team believes that every nonconformity requires a full CAPA.

And you'll have all these meaningless 'retrainings' as corrective actions or 'training passed' as effectiveness criteria.

The key to preventing this is being precise about:

1. What stays at the NC level (= correction only)
2. When to escalate to CAPA (= corrective action)
3. How to document the decision (= risk-based)

Your process needs to support smart decisions, not create unnecessary work.

Otherwise it's more like this:

Garbage in, garbage out.
________________
I post about effective NC & CAPA management for medical device companies. Follow Georg Digel to remove the complexity from your processes.

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